FDA recall D-0413-2022

Product

Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.

Reason for recall

Lack of Assurance of Sterility

Distribution

nationwide

Key facts

Status

Terminated

Initiation date

2021-12-06

Report date

2022-02-02

Termination date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Colchester, VT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0413-2022